Core 011 ? Project Summary/Abstract ? Protocol Review and Monitoring System The Chao Family Comprehensive Cancer Center (CFCCC) Protocol Review and Monitoring System is implemented through the activities of its review committees and is supported and facilitated by administrative staff. The system is designed to increase the translation of CFCCC discoveries from the laboratory into the clinic and improve the efficiency of opening and managing clinical trials. Proposed protocols are brought forward by individual investigators to either a Disease-Oriented Team (DOT) or a corresponding multidisciplinary tumor board. These groups are charged with determining their level of interest in and commitment to the trial, whether the scientific question addressed is of sufficient importance to their field, the appropriateness of the trial design, the potential to accrue to the trial, any conflicts with existing studies and prioritization, and possible correlative translation science that could be captured. The principal charge of the Protocol Review and Monitoring Committee (PRMC) is evaluation of scientific quality and progress. For scientific quality, the PRMC will evaluate only institutional, investigator-initiated trials (IITs) that have not undergone this process elsewhere. Cooperative group and pharmaceutical industry trials, which have been vetted on a national level, are exempt from this review. In addition to scientific quality, the PRMC assesses whether the clinical trials office has the appropriate resources (e.g. data management, pharmacy, nursing, etc.) to support the trial, how the trial fits into the broad interests of the Cancer Center (e.g. portfolio balance across disease areas, potential for accrual of women and minorities, whether the trial is an IIT), and the track record of the principal investigator in accruing to previous trials. The PRMC will continue to routinely review scientific progress for all open trials and also consider data timeliness and quality. The PRMC may disapprove a trial, approve a trial, or request additional information from the PI. The record of deliberations of the PRMC and correspondence with the PI is documented in the clinical trials management system, OnCore.